The present invention relates generally to medical devices and methods, and more particularly to devices and methods for evaluating and treating urinary and fecal incontinence by using proprioceptive neuromuscular facilitation and sensation, as well as devices and methods to facilitate urinary drainage and pelvic organ support.
Urinary incontinence is believed to affect 15% to 30% of noninstitutionalized persons over the age of 60, and more then 50% of elderly persons (over the age of 60) who reside in nursing homes.
The presently available modes of treatment for urinary incontinence fall into four general categories, namely: i) management apparatus, ii) behavioral, iii) pharmacologic, and iv) surgical.
The management apparatus modes of treatment generally comprise absorbent and/or catheter structures worn by a user to retain any urinary and/or fecal incontinence. In their simplest forms, such devices comprise diaper-like structures which must be periodically changed by the user. Although such management apparatus has proven generally effective in masking the results of incontinence, they are uncomfortable to wear, difficult to change, and oftentimes fail during use thereby embarrassing the user.
The use of behavioral training as a treatment for urinary and/or fecal incontinence can involve numerous behavioral techniques including; bladder re-training (e.g., voiding on a timed schedule), and/or the performance of exercises (e.g., Kegel exercises) to strengthen and retrain a group of muscles collectively known as the xe2x80x9cpelvic floor muscles.xe2x80x9d As an adjunct to these behavioral training techniques, various intravaginal and/or intra-anal devices may be utilized to facilitate the performance of such pelvic muscle training exercises. Such intravaginal and/or intra-anal devices have included simple weighted apparatus such as pessaries or intravaginal cones. Exemplary of such prior art pessaries are the pessaries manufactured by Milex Wester Company, 639 North Fairfax, Los Angeles, Calif. 90036; while an example of such weighted cone device is the xe2x80x9cFEMINAxe2x80x9d cone manufactured by Dacomed Corporation, 1701 East 79th Street, Minneapolis, Minn., 55425. Other types of prior art devices include pneumatic-type devices and electromyographic (EMC) transducers or sensors which are insertable into or placed just outside of the vagina and/or anus to obtain EMG data indicative of baseline pelvic floor muscle tone and/or contraction(s) of the pelvic floor muscles during the performance of specific muscle contraction exercises. Such EMG data may be usable for diagnostic purposes as well as for monitoring the performance and/or effect of muscle training exercises. Some EMG devices have included means for providing visual or auditory feedback to assist the patient in the performance of pelvic floor muscle exercises (e.g., Myoexorciser III, available from Verimed 1401 East Broward Boulevard, Suite 200, Fort Lauderdale, Fla. 33301 and the PRS 8900 Office System made by Incare Medical Products, Libertyville, Ill. 60048.
Additionally, the prior art has included at least one transvaginal electrical stimulation device which is operative to deliver periodic or timed electrical stimulation to the pelvic floor muscles and nerves. Such electrical stimulation causes involuntary contraction of the pelvic floor muscles and may serve as an adjunct to the performance of volitional exercise and/or other behavioral training techniques (e.g., Microgyn II Stimulation Device, InCare Medical Products, Division of Hollister Incorporated, 2000 Hollister Drive, LibertyVille, Ill., 60048 and also the Innova Feminine Incontinence Treatment System available from EMPI, Inc., 1275 Grey Fox Road, St. Paul, Minn. 55112).
Although some of or all of the above-described devices and systems for exercise and/or training of the pelvic floor muscles may be effective in the treatment of urinary incontinence, there remains a need for the development of improved devices and systems which are capable of strengthening and training the pelvic floor muscles in minimal time, with minimal assistance from physicians or other health care professionals as well as a system which serves to remind a user to perform muscle exercises and to provide proprioceptive input to assist the user in exercising and strengthening desired muscles.
The prior art pharmacologic treatment of urinary incontinence typically involves the long term administration of drugs. Such pharmacologic treatment may result in drug-related side effects. Also, the efficacy of such pharmacologic treatment is frequently limited and largely dependant upon the patient""s ability or willingness to comply with the prescribed drug dosage schedule.
The prior art surgical modes of treatment of urinary incontinence typically involve the performance of one or more major surgeries procedures under anesthesia. These major surgical procedures can be associated with significant risks and may sometime result in post-surgical failure, infections, or other complications. Also, these surgical procedures typically result in significant expense to the patient and/or the patient""s third party insurer.
As such, there exists a substantial need in the art for an incontinence treatment system and methodology which reduces or eliminates the need for prior art management apparatus and/or surgical treatments, reduces the use of long-term drug administration, accentuates muscle strengthening and training while reminding a patient to conduct muscle strengthening exercise, as well as provide a proprioceptive input to assist the patient in contracting the appropriate muscles and/or muscle groups necessary for the effective treatment of incontinence.
Additionally, in connect therewith, there is a need in the art to facilitate the drainage of urine from the bladder of a patient. In this regard, systems to collect urine for quantitative and qualitative analysis and facilitate bladder drainage, which typically comprise an indwelling rubber catheter disposed within the urethra of the patient, such as a Foley catheter, suffer from the draw back of being difficult and uncomfortable to utilize and further, are less than optimal to collect urine, particularly with respect from female patients. Additionally, it is well recognized that long-term use of indwelling catheters is a significant source of bacteriuria and UTI (urinary tract infection). Indeed, there are reported cases of sepsis and death from severe UTI caused by such indwelling catheters.
A condition further related to incontinence is prolapse, i.e., the slipping down of an organ or part from its normal position, of the uterus, bladder (cystocele), vagina, and/or rectum (rectocele). With respect to prolapse of the uterus, such condition occurs when the uterus falls into the vagina due to stretching and laxity of its supporting structures. Cystocele/rectocele are conditions where the bladder/rectum herniate into, and at times out, of the vagina.
Typically, pessary devices are utilized to provide the necessary pelvic support for the various aforementioned conditions. Such pessary devices, which are well-known to those skilled in the art, can take the form of ring pessaries, folding pessaries, such as the Hodge folding pessary or Risser folding pessary, cube pessaries, and gellhorn pessaries, all of which are designed to be inserted within the anatomical passageway that is the subject of the prolapse and remain resident therein to provide the necessary structural support.
While such pessary devices are generally effective in providing the necessary structural support to thus maintain the organ or part of the body affected by the prolapse in its normal position, such pessary devices currently in use suffer from numerous drawbacks. Specifically, such devices are ill-suited to remain firmly anchored within the anatomical passageway within which the same are received. Moreover, such conventional pessary devices are difficult to be inserted and withdrawn from their intended anatomical passageway. Still further, most conventional pessary devices poorly adapt to the specific contours of the specific anatomy of the given patient and are thus unable to form a xe2x80x9ccustomxe2x80x9d fit, which would be most ideal for providing the optimal degree of structural support. Accordingly, there is further a need in the art for a pessary device that can be easily inserted within an anatomical passageway and remain firmly anchored therein. There is also a need for a pessary device capable of forming a custom-fit to a given patient""s particular specific anatomy such that optimal support structure can be formed.
In accordance with the present invention, there is provided a device which is insertable into a pelvic anatomical passageway of a patient (e.g. , the vagina or anus) to identify target pelvic floor muscles and/or muscle groups responsible for fecal and/or urinary incontinence and facilitate the performance of exercises to strengthen the same. According to a first preferred embodiment, the device generally comprises a device body having a generally arrowhead-shaped distal portion having a flattened, generally cross-sectional configuration, and intermediate shaft portion, and a proximal base portion that is sized and contoured to be inserted into a pelvic anatomical passageway. The distal portion is specifically designed to anchor the device body within the target anatomical passageway with the intermediate and proximal portions of the device body being designed to extend therefrom to thus facilitate manual manipulation of the device body during insertion and withdrawal of the device from the anatomical passageway.
The distal portion is alternately transitionable between a non-stimulus mode wherein the distal portion simply remains at rest while anchored within an anatomical passageway, and a stimulus mode configuration whereby a perceptible stimulus is produced against the region of the anatomical passageway to which the distal portion of the device is anchored to thus remind the patient to perform the pelvic wall muscle exercises. The stimulus produced in the stimulus mode is preferably generated from a stimulus producing device disposed within the distal portion of the device body, and may preferably comprise a vibrator or pressure-exerting device.
With respect to the pressure-exerting device, such device is specifically designed to alternately transition between i) a rest mode configuration wherein such device causes the distal portion of the device body to exert no more than a base line amount of pressure against a predetermined region of the anatomical passageway within which the device body is located and, ii) an exercise mode configuration wherein the device causes the distal portion of the device body to exert more than the base line amount of pressure against the predetermined region of the anatomical passageway within which the device body is inserted.
A small battery and battery-powered motor may be mounted on or within the device to drive the transformation of the device between the stimulus mode configuration and the non-stimulus mode configuration. Additionally, a timer or other type of switching apparatus may be mounted on or within the distal portion of the device to trigger and control the timing, duration, repetitions, and frequency of transformation of the device between the rest mode configuration and the exercise mode configuration, at predetermined times. Still further in accordance with the invention, a remote controlled triggering device may be used in addition to, or in place of, a timer or other control apparatus mounted on or within the device. Such remote control apparatus may be utilized to trigger, control and/or schedule all operational parameters of transformation of the device, back and forth, between its rest mode configuration and exercise mode configuration, from a remote location.
In an alternative configuration, the distal portion, as opposed to being alternately transitionable between stimulus and non-stimulus modes, has disposed therewithin an exercising monitoring device designed and configured to monitor the frequency and duration the patient performs the prescribed strengthening exercises. Such monitoring device further identifies which muscle or muscle groups are actually being exercised, as well as evaluates the progress made by the patient in strengthening the same. According to one particular embodiment, such exercise monitoring device may utilize biofeedback to provide the patient with a perceptible signal consistent with the frequency and effectiveness of the patient""s performance of the exercise regimen to thus enable the patient to keep track of and consciously control the progress made in practicing such exercise regimen.
In a second preferred embodiment, the device comprises the combination of a device body constructed in accordance to the first embodiment, but further includes a remote enclosure coupled thereto via a cord. Within the enclosure is a power source, timing circuit electronics, and switching devices to enable the user or healthcare practitioner to selectively implement the operation of a stimulus producing apparatus, and more particularly, a bilateral pressure-exerting mechanism, disposed within the distal portion of the device body, to thus generate a perceptible stimulus to thus remind the user to perform the desired strengthening exercises.
In a third preferred embodiment, the device comprises a device body having the distal, intermediate and proximal portions, as per the first and second embodiments, and further includes a novel stimulus producing apparatus comprising at least one, and preferably a plurality of protuberances mounted on respective ones of a pair of gears disposed within the distal portion of the device body. A third gear mounted to an axle and disposed intermediate the first and second gears is provided to selectively rotate the gears having to protuberances formed thereon such that the protuberances bulge through and rotate about the distal portion of the device body. As a result, there is thus generated a perceptible stimulus to thus remind the user to perform the desired strengthening exercises.
In yet another preferred embodiment, the device comprises a device body having the distal, intermediate, and proximal portions discussed above, in combination with a novel pressure-exerting stimulus producing apparatus. With respect to the latter, such stimulus producing apparatus comprises the combination of a pair of pressure-exerting arm members or flippers disposed within the distal portion of the device body that are operative to extend outwardly therefrom, such that such pressure is exerted upon the surrounding anatomy to which the distal portion is anchored. The increased pressure exerted thereby thus generates the perceptible stimulus necessary to remind the user to perform the necessary strengthening exercises for the target muscles and/or muscle groups.
There is additionally provided in an alternative embodiment a device capable of being anchored within an anatomical passageway for facilitating urinary drainage. According to such embodiment, the device comprises of the combination of a generally annular base having a flexible mushroom-shaped anchor member affixed thereto, the latter being designed and configured to nest and become seated within an anatomical passageway. A port formed upon the annular base is designed and configured to be axially aligned with and sealed to the urethral meatus once the anchor member is seated within the passageway so that the flow of urine from the bladder of the user is facilitated.
In a further preferred embodiment, there is provided a device for facilitating urinary drainage that likewise incorporates a generally annular base having an anchor member formed thereon, the latter being selectively transitional between a first insertion mode, wherein the device assumes a first insertion configuration which enables the device to be easily inserted within the anatomical passageway, and an anchor configuration, wherein such anchor member selectively expands and compresses radially about the anatomical passageway to thus cause the same to become firmly anchored thereat. As in the above embodiment, a port formed on the annular base is designed and configured to be axially aligned with and sealed to the urethral meatus once the anchor member is seated within the passageway.
In addition to facilitating urinary drainage, such anchor mechanism may be utilized independently to serve as a pessary device to treat prolapse of either the uterus, rectum, or vagina. Such anchoring device is particularly well-suited to cause the urethra to assume its proper physiological position. The anchoring device may be further utilized to develop a custom pessary that is specifically designed and configured to accommodate and adapt to the anatomy of a particular individual.
Still further in accordance with the invention, there are provided methods of treating urinary and/or fecal incontinence in a patient. In general, the method comprises the steps of inserting a device of the forgoing character into either the vagina or anus, and utilizing the device to intermittently deliver increased stretch/resistance/vibration/pressure or heat stimuli against the wall and/or adjacent muscles of the vagina or anus to facilitate the performance of pelvic muscle strengthening exercises by the patient in whom the device is inserted. Additionally in accordance with the present invention, there is provided a method for facilitating drainage of urine from the bladder of an individual, and particularly female. Such method comprises the steps of inserting an anchoring device of the foregoing character into an anatomical passageway and aligning and mating a port with the urethral meatus of the patient to thus provide a continual passageway through which urine may pass from the body. Still further, there is provided novel pessary devices and methods for treating prolapse of either the uterus, rectum, or vagina, as well as devices and methods measuring and determining the specific dimensions of an anatomical passageway to form custom pessary devices for use therewith.